nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

reMARQable nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01824394
• Other study ID #: reMARQable
• Status: Terminated
• Phase: Phase 3
• Start date: April 1, 2013
• Est. completion date: November 26, 2017

Study information

• Verified date: January 2019
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To demonstrate safety and effectiveness of nMARQ Catheter System [nMARQ] compared with THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 481
• Est. completion date: November 26, 2017
• Est. primary completion date: November 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with symptomatic paroxysmal AF who have had at least one AF episode documented within one (1) year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.

2. Patients who have failed at least one antiarrhythmic drug (AAD; class I or III, or atrioventricular (AV) nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic AF, or intolerance to the AAD.

3. Pre-procedure anticoagulation on warfarin, rivaroxaban, or apixaban.

4. Age 18 years or older.

5. Signed Patient Informed Consent Form (ICF).

6. Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

Exclusion Criteria:

1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.

2. Previous ablation for atrial fibrillation.

3. Patients on amiodarone at any time during the past 3 months prior to enrollment.

4. AF episodes lasting > 7 days.

5. Any cardiac surgery within the past 60 days (2 months).

6. Any valvular cardiac surgical procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).

7. Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months).

8. Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months).

9. Documented left atrial thrombus on imaging.

10. History of a documented thromboembolic event within the past one (1) year.

11. Diagnosed atrial myxoma.

12. Presence of implanted cardioverter defibrillator (ICD).

13. Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.

14. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.

15. Women who are pregnant (as evidenced by pregnancy test if subject is of child-bearing age and potential) or breast feeding.

16. Acute illness or active systemic infection or sepsis.

17. Unstable angina.

18. Myocardial infarction within the previous 60 days (2 months).

19. Left ventricular ejection fraction <40%.

20. History of blood clotting or bleeding abnormalities.

21. Contraindication to anticoagulation (i.e., heparin, dabigatran, Vitamin K Antagonists such as warfarin).

22. Life expectancy less than 365 days (12 months).

23. Enrollment in an investigational study evaluating another device or drug.

24. Uncontrolled heart failure or NYHA Class III or IV heart failure.

25. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.

26. Presence of a condition that precludes vascular access.

27. Left atrial size >50 mm.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• nMARQ Navigation Catheters

• NaviStar ThermoCool Catheters

Locations

Country	Name	City	State
Belgium	Imelda Ziekenhuis	Imeldalaan	Bonheiden
Belgium	Clinique Saint-Pierre Ottignies	Ottignies
Czechia	Nemocnice Na Homolce	Prague
Hungary	Semmelweis University Heart and Vascular Center	Budapest	Városmajor U
Italy	Ospedale Generale Regionale "F. Miulli"	Acquaviva Delle Fonti	Bari
Italy	Ospedale Cardinal Massaia	Asti
Italy	Centro Cardiologico Monzino	Milano
Italy	A.O.U. Città della Salute e della Scienza di Torino - Ospedale San Giovanni Battista - Molinette	Torino
United Kingdom	Glenfield Hospital	Leicester	Leicestershire
United Kingdom	Freeman Hospital	Newcastle
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Texas Cardiac Arrhythmia Research - St. David's	Austin	Texas
United States	University of Alabama Hospital	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University Medical Center, The	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	St. Luke's Episcopal Hospital	Houston	Texas
United States	St. Vincent's Medical Center	Jacksonville	Florida
United States	University of Kansas Hospital	Kansas City	Kansas
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Good Samaritan Hospital Los Angeles	Los Angeles	California
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Morristown Medical Center	Morristown	New Jersey
United States	Intermountain Medical Center	Murray	Utah
United States	Centennial Heart	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Florida Hospital Memorial Medical Center	New Smyrna Beach	Florida
United States	Mount Sinai School of Medicine, The	New York	New York
United States	New York University	New York	New York
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Oklahoma Heart Hospital	Oklahoma City	Oklahoma
United States	Florida Hospital	Orlando	Florida
United States	Stanford Hospital and Clinics	Palo Alto	California
United States	Einstein Medical Center Philadelphia	Philadelphia	Pennsylvania
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	Arizona Heart Rhythm Center	Phoenix	Arizona
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Sequoia Hospital	Redwood City	California
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia
United States	Valley Hospital	Ridgewood	New Jersey
United States	Swedish Medical Center	Seattle	Washington
United States	Our Lady of Lourdes Medical Center	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  Hungary,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Early Onset Primary Adverse Events	The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs	30 days post-procedure
Primary	Incidence of Early Onset Primary Adverse Events for the Intent-to-Treat and As-Treated Population	The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs	30 days post-procedure